User's Manual

Lumenis
®
Pulse
TM
50H / 100H Laser Systems Indications for Use
UM-20006520DE, Rev. A Page 24
Indications for Use
The Lumenis Pulse 50H and 100H system with delivery devices and
accessories are intended for use in surgical procedures involving open,
laparoscopic and endoscopic ablation, vaporization, excision, incision,
and coagulation of soft tissue in medical specialties including: urology;
urinary lithotripsy; arthroscopy; discectomy; endo-nasal surgery;
gynecological surgery; pulmonary surgery; gastroenterology surgery;
dermatology and general surgery.
Contraindications
The use of a laser instrument for an application is at the physician’s
discretion except in cases where the indication has been contraindicated.
• Inability to receive endoscopic or laparoscopic treatment.
• Intolerance to anesthesia.
• Resection or excision of large, highly vascularized organs.
Specific Contraindications in Urology
• Carcinoma of the prostate
Specific Contraindications in Gynecology
• Septic peritonitis
• Intestinal obstruction
• Septic shock
• Resection or excision of large, highly vascularized organs.
NOTE:
Lumenis has no clinical information concerning the safety of laser
treatment on pregnant or nursing women.
Warnings and Precautions
This section contains warnings and precautions that are applicable to
surgical procedures specifically related to the use of this system.
• Holmium lasers are intended solely for use by physicians trained in the
use of the Ho:YAG (2.1 µm) wavelength.
• Incorrect treatment settings can cause serious tissue damage. Therefore,
it is recommended that you use the lowest acceptable treatment settings